MN-ST.-JUDE-MEDICAL,-INC

St. Jude Medical Announces European Launch of the Latest in PressureWire Guidewire Technology to Measure Pressure Differences Across Narrowed Coronary Arteries

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced CE Mark approval and European launch of the
PressureWire™ X Guidewire fractional flow reserve (FFR) Measurement
System. Designed to identify the severity of narrowings in the coronary
arteries of patients with coronary artery disease (CAD), FFR
measurement
allows for a more effective assessment of coronary
lesions (blockages), resulting in more accurate diagnosis. The company
will showcase the new PressureWire X guidewire technology at the EuroPCR
2016
meeting, May 17-20, 2016 in Paris. The PressureWire X guidewire
European launch will include a measured rollout to targeted countries
throughout 2016.

PressureWire™ FFR guidewire measurement supports more accurate lesion
assessment during percutaneous coronary intervention (PCI) to help
physicians make more informed treatment decisions for their patients,
which has been shown to improve patient outcomes. The newly launched
PressureWire X guidewire offers enhanced durability and improved
handling in either a cabled or wireless configuration, both with the
accuracy and reliability physicians need when treating patients with CAD.

“Fractional flow reserve has become an indispensable tool for assessing
coronary lesions and making informed treatment decisions during
percutaneous coronary intervention,” said Dr. Bernard De Bruyne of the
CVC Aalst, Belgium. “The improved design of the new PressureWire X
guidewire tip will simplify the fractional flow reserve procedure by
enabling access to lesions in patients with tortuous, complex anatomy.”

Designed to provide better durability and shape retention than currently
available pressure guidewires, the new PressureWire X guidewire aims to
provide physicians with a tip that can be shaped and re-shaped during
PCI, which enables it to be used to assess multiple lesions, even in
patients with complex anatomy. Allowing physicians to better navigate
each patient’s unique anatomy will support improved assessment and
diagnosis of coronary blockages, which can lead to improved
decision-making on how best to restore blood flow to the heart. The
latest PressureWire X guidewire is also intended to support faster
procedure times, ensuring patients undergo more efficient PCI procedures.

The use of FFR to optimize PCI is supported by strong evidence, such as
the FAME
(F
ractional Flow Reserve (FFR) vs. A
ngiography
in M
ultivessel E
valuation)
trials, which found that St. Jude Medical™ PressureWire™ technology can
improve patient outcomes over angiography alone in patients with CAD.
The FAME body of evidence also demonstrated reductions in the risk of
death or heart attack in patients undergoing PCI, as well as reduced
health care costs for patients whose treatment was guided by FFR
technology.

In addition to clinical trails designed to assess the positive outcomes
associated with FFR technology, St. Jude Medical has launched the
PRESSUREwire REGISTRY (P
ractical
Evaluation of Fractional Flow R
eserve
(FFR) and its As
sociation Alternate Indices
Du
ring R
outine
Clinical Proce
dures), a multicenter
clinical trial to determine the routine use of FFR measurement and
clinical outcomes of FFR-guided PCI in patients with acute coronary
syndrome (ACS), a major cause of global morbidity and mortality.

“St. Jude Medical strives to provide physicians with fractional flow
reserve pressure guidewire options that are backed by clinical data and
match the handling performance of conventional workhorse PCI guidewires,
which is a combination that we have always prioritized in designing and
developing the PressureWire series of FFR guidewires,” said Dr. Mark
Carlson, chief medical officer and vice president of global medical
affairs at St. Jude Medical. “The new PressureWire X guidewire shows our
dedication to providing physicians with cost-effective, easy-to-use
technologies that aid them in making the best treatment decisions for
their patients.”

About the Original FAME Trial

The original St. Jude Medical sponsored FAME (F
ractional
Flow Reserve (FFR) vs. A
ngiography
in M
ultivessel E
valuation)
Trial compared outcomes of patients whose treatment was guided by FFR to
those whose treatment was only guided by angiography. Results from the
landmark trial demonstrated improved clinical outcomes in patients with
stable coronary artery disease and two or three vessel disease.

The 12-month results published in the New England Journal of Medicine
demonstrated that instances of major adverse cardiac events were reduced
by 28 percent for patients whose treatment was guided by FFR rather than
by standard angiography alone. Two year results demonstrated that
patients who received FFR-guided treatment continued to experience
improved outcomes over time, including a 34 percent risk reduction in
death or heart attack.

About Fractional Flow Reserve (FFR)

Fractional Flow Reserve (FFR) is an index determining the functional
severity of narrowings in the coronary arteries, and it is measured by
PressureWire™ Aeris™ or PressureWire™ Certus™ FFR measurement system.
FFR specifically identifies which coronary narrowings are responsible
for significantly obstructing the flow of blood to a patients’ heart
muscle (called ischemia), and it is used by the interventional
cardiologist to direct coronary interventions and assess results for
improved treatment outcomes.

About St. Jude Medical

St. Jude Medical is a leading global medical device manufacturer and is
dedicated to transforming the treatment of some of the world's most
expensive epidemic diseases. The company does this by developing
cost-effective medical technologies that save and improve lives of
patients around the world. Headquartered in St. Paul, Minn., St. Jude
Medical employs approximately 18,000 people worldwide and has five major
areas of focus that include heart failure, atrial fibrillation,
neuromodulation, traditional cardiac rhythm management and
cardiovascular. For more information, please visit sjm.com
or follow us on Twitter @SJM_Media
.

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risks and uncertainties. Such forward-looking statements include the
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clinical successes, anticipated regulatory approvals and future product
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the forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company’s control and the
risk factors and other cautionary statements described in the Company’s
filings with the SEC, including those described in the Risk Factors and
Cautionary Statements sections of the Company’s Annual Report on Form
10-K for the fiscal year ended January 2, 2016 and Quarterly Report on
Form 10-Q for the fiscal quarter ended April 2, 2016. The Company does
not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.